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New treatment option for Chronic Kidney Diseases
Official title Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
ClinicalTrials.gov ID: NCT06560801
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Female and male patients aged between 18 and 75 years
- Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes...
- Females of child bearing potential must be using adequate contraceptive precautions
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
You likely can't join if
- Type 1 diabetes mellitus.
- HbA1c \> 10%
- Use of SGLT-2 inhibitor within the past 2 months
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study...
- eGFR \<25 ml/min/1.73m² (CKD-EPI Formula).
- Uncontrolled arterial hypertension (RR \> 180/110 mmHg).
See the full eligibility criteria
- Female and male patients aged between 18 and 75 years
- Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status
- Females of child bearing potential must be using adequate contraceptive precautions
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
- Type 1 diabetes mellitus.
- HbA1c \> 10%
- Use of SGLT-2 inhibitor within the past 2 months
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion.
- eGFR \<25 ml/min/1.73m² (CKD-EPI Formula).
- Uncontrolled arterial hypertension (RR \> 180/110 mmHg).
- Congestive heart failure (CHF) NYHA stage IV.
- Recurrent urinary tract infections (bacterial or fungal)
- Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug.
- Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range.
- Antihypertensives are allowed but should be kept stable throughout the study period.
- Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period.
- Drug or alcohol abusus
- Pregnant or breast-feeding patients
- Patients with contraindications to MRI
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Bavaria, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.